[Federal Register Volume 77, Number 196 (Wednesday, October 10, 2012)]
[Rules and Regulations]
[Pages 61515-61518]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-24776]
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ENVIRONMENTAL PROTECTION AGENCY
40 CFR Part 180
[EPA-HQ-OPP-2011-0949; FRL-9361-7]
Alkyl Amines Polyalkoxylates; Exemption From the Requirement of a
Tolerance
AGENCY: Environmental Protection Agency (EPA).
ACTION: Final rule.
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SUMMARY: This regulation amends the exemption from the requirement of a
tolerance for residues alkyl amines polyalkoxylates under 40 CFR
180.920 and 40 CFR 180.930 to include the additional Chemical Abstract
Service Registry Number (CAS Reg. No.) 1266162-49-5. BASF Corporation
submitted a petition to EPA under the Federal Food, Drug, and Cosmetic
Act (FFDCA), requesting an amendment to an existing requirement of a
tolerance.
DATES: This regulation is effective October 10, 2012. Objections and
requests for hearings must be received on or before December 10, 2012,
and must be filed in accordance with the instructions provided in 40
CFR part 178 (see also Unit I.C. of the SUPPLEMENTARY INFORMATION).
ADDRESSES: The docket for this action, identified by docket
identification (ID) number EPA-HQ-OPP-2011-0949 is available at http://www.regulations.gov or at the Office of Pesticide Programs Regulatory
Public Docket (OPP Docket) in the Environmental Protection Agency
Docket Center (EPA/DC), EPA West Bldg., Rm. 3334, 1301 Constitution
Ave. NW., Washington, DC 20460-0001. The Public Reading Room is open
from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal
holidays. The telephone number for the Public Reading Room is (202)
566-1744, and the telephone number for the OPP Docket is (703) 305-
5805. Please review the visitor instructions and additional information
about the docket available at http://www.epa.gov/dockets.
FOR FURTHER INFORMATION CONTACT: Elizabeth Fertich, Registration
Division (7505P), Office of Pesticide Programs, Environmental
Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460-
0001; telephone number: (703) 347-8560; email address:
fertich.elizabeth@epa.gov.
SUPPLEMENTARY INFORMATION:
I. General Information
A. Does this action apply to me?
You may be potentially affected by this action if you are an
agricultural producer, food manufacturer, or pesticide manufacturer.
The following list of North American Industrial Classification System
(NAICS) codes is not intended to be exhaustive, but rather provides a
guide to help readers determine whether this document applies to them.
Potentially affected entities may include:
Crop production (NAICS code 111).
Animal production (NAICS code 112).
Food manufacturing (NAICS code 311).
Pesticide manufacturing (NAICS code 32532).
B. How can I get electronic access to other related information?
You may access a frequently updated electronic version of 40 CFR
part 180 through the Government Printing Office's e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?&c=ecfr&tpl=/ecfrbrowse/Title40/40tab_02.tpl.
C. How can I file an objection or hearing request?
Under FFDCA section 408(g), 21 U.S.C. 346a, any person may file an
objection to any aspect of this regulation and may also request a
hearing on those objections. You must file your objection or request a
hearing on this regulation in accordance with the instructions provided
in 40 CFR part 178. To ensure proper receipt by EPA, you must identify
docket ID number EPA-HQ-OPP-2011-0949 in the subject line on the first
page of your submission. All objections and requests for a hearing must
be in writing, and must be received by the Hearing Clerk on or before
December 10, 2012. Addresses for mail and hand delivery of objections
and hearing requests are provided in 40 CFR 178.25(b).
In addition to filing an objection or hearing request with the
Hearing Clerk as described in 40 CFR part 178, please submit a copy of
the filing (excluding any CBI) for inclusion in the public docket.
Information not marked confidential pursuant to 40 CFR part 2 may be
disclosed publicly by EPA without prior notice. Submit the non-
[[Page 61516]]
CBI copy of your objection or hearing request, identified by docket ID
number EPA-HQ-OPP-2011-0949, by one of the following methods:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the online instructions for submitting comments. Do not submit
electronically any information you consider to be Confidential Business
Information (CBI) or other information whose disclosure is restricted
by statute.
Mail: OPP Docket, Environmental Protection Agency Docket
Center (EPA/DC), (28221T), 1200 Pennsylvania Ave. NW., Washington, DC
20460-0001.
Hand Delivery: To make special arrangements for hand
delivery or delivery of boxed information, please follow the
instructions at http://www.epa.gov/dockets/contacts.htm.
Additional instructions on commenting or visiting the docket, along
with more information about dockets generally, is available at http://www.epa.gov/dockets.
II. Petition for Exemption
In the Federal Register of March 14, 2012 (77 FR 15012) (FRL-9335-
9), EPA issued a notice pursuant to FFDCA section 408, 21 U.S.C. 346a,
announcing the filing of a pesticide petition (PP 1E7931) by BASF
Corporation, 100 Campus Drive; Florham Park, NJ 07932. The petition
requested that 40 CFR 180.920 and 180.930 be amended by modifying an
exemption from the requirement of a tolerance for residues of N,N-Bis-
[alpha]-ethyl-[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated
and unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-
60 moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8,70955-14-
5, 73246-96-5); herein referred to as alkyl amines polyalkoxylates.
Specifically, the petition requested that the exemption also include
the alkyl amines polyalkoxylate described by CAS Reg. No. 1266162-49-5.
That notice referenced a summary of the petition prepared by BASF
Corporation, the petitioner, which is available in the docket, http://www.regulations.gov. There were no comments received in response to the
notice of filing.
In this petition, BASF Corporation claims that the chemical
represented by CAS Reg. No. 1266162-49-5 (poly(oxy-1,2-ethandiyl),
[alpha],[alpha]'-[[(2-propylheptyl)imino]di-2,1-ethanediyl]bis[[omega]-
hydroxy-) is covered by the published tolerance exemption for alkyl
amines polyalkoxylates and that no further data or review is required
to amend the existing tolerance exemption to include the additional CAS
Reg. No.
III. Inert Ingredient Definition
Inert ingredients are all ingredients that are not active
ingredients as defined in 40 CFR 153.125 and include, but are not
limited to, the following types of ingredients (except when they have a
pesticidal efficacy of their own): Solvents such as alcohols and
hydrocarbons; surfactants such as polyoxyethylene polymers and fatty
acids; carriers such as clay and diatomaceous earth; thickeners such as
carrageenan and modified cellulose; wetting, spreading, and dispersing
agents; propellants in aerosol dispensers; microencapsulating agents;
and emulsifiers. The term ``inert'' is not intended to imply
nontoxicity; the ingredient may or may not be chemically active.
Generally, EPA has exempted inert ingredients from the requirement of a
tolerance based on the low toxicity of the individual inert
ingredients.
IV. Aggregate Risk Assessment and Determination of Safety
Section 408(c)(2)(A)(i) of FFDCA allows EPA to establish an
exemption from the requirement for a tolerance (the legal limit for a
pesticide chemical residue in or on a food) only if EPA determines that
the tolerance is ``safe.'' Section 408(b)(2)(A)(ii) of FFDCA defines
``safe'' to mean that ``there is a reasonable certainty that no harm
will result from aggregate exposure to the pesticide chemical residue,
including all anticipated dietary exposures and all other exposures for
which there is reliable information.'' This includes exposure through
drinking water and in residential settings, but does not include
occupational exposure. Section 408(b)(2)(C) of FFDCA requires EPA to
give special consideration to exposure of infants and children to the
pesticide chemical residue in establishing a tolerance and to ``ensure
that there is a reasonable certainty that no harm will result to
infants and children from aggregate exposure to the pesticide chemical
residue * * *.''
EPA establishes exemptions from the requirement of a tolerance only
in those cases where it can be clearly demonstrated that the risks from
aggregate exposure to pesticide chemical residues under reasonably
foreseeable circumstances will pose no appreciable risks to human
health. In order to determine the risks from aggregate exposure to
pesticide inert ingredients, the Agency considers the toxicity of the
inert ingredient in conjunction with possible exposure to residues of
the inert ingredient through food, drinking water, and through other
exposures that occur as a result of pesticide use in residential
settings. If EPA is able to determine that a finite tolerance is not
necessary to ensure that there is a reasonable certainty that no harm
will result from aggregate exposure to the inert ingredient, an
exemption from the requirement of a tolerance may be established.
Consistent with FFDCA section 408(c)(2)(A), and the factors
specified in FFDCA section 408(c)(2)(B), EPA has reviewed the available
scientific data and other relevant information in support of this
action. EPA has sufficient data to assess the hazards of and to make a
determination on aggregate exposure for alkyl amine polyalkoxylates
including exposure resulting from the exemption established by this
action. EPA's assessment of exposures and risks associated with alkyl
amine polyalkoxylates follows.
The Agency agrees with the petitioner that CAS Reg. No. 1266162-49-
5 is an alkyl amine polyalkoxylate similar to the other alkyl amine
polyalkoxylates present in the exemption for N,N-Bis-[alpha]-ethyl-
[omega]-hydroxypoly(oxy-1,2-ethanediyl) C8-C18 saturated and
unsaturated alkylamines; the poly(oxy-1,2-ethanediyl) content is 2-60
moles (CAS Reg. Nos. 10213-78-2, 25307-17-9, 26635-92-7, 26635-93-8,
288259-52-9, 58253-49-9, 61790-82-7, 61791-14-8, 61791-24-0, 61791-26-
2, 61791-31-9, 61791-44-4, 68155-33-9, 68155-39-5, 68155-40-8, 70955-
14-5, 73246-96-5). In 2009, in establishing the exemption for the alkyl
amine polyalkoxylates, EPA assessed the safety of the alkyl amine
polyalkoxylates generally using worst case exposure assumptions. (74 FR
28616) (FRL-8418-6). EPA concluded that that assessment showed that
exempting the alkyl amine polyalkoxylates from the requirement from a
tolerance would be safe. Inclusion of chemical described by the CAS
Reg. No. 1266162-49-5 in the risk assessment for the alkyl amine
polyalkoxylates would in no way alter that prior risk assessment given
the generic findings on toxicity and the worst case exposure
assumptions used in that risk assessment. Accordingly, based on the
findings in that earlier rule, EPA has determined that there is a
reasonable certainty that no harm to any population subgroup, including
infants and children, will result from aggregate exposure to alkyl
amine polyalkoxylates, including the chemical described by the CAS Reg.
No.
[[Page 61517]]
1266162-49-5, under reasonably foreseeable circumstances. Therefore,
the amendment of an exemption from tolerance under 40 CFR 180.920 and
180.930 for residues of alkyl amine polyalkoxylates to include the
chemical described by the CAS Reg. No. 1266162-49-5 is safe under FFDCA
section 408.
V. Other Considerations
A. Analytical Enforcement Methodology
An analytical method is not required for enforcement purposes since
the Agency is establishing an exemption from the requirement of a
tolerance without any numerical limitation.
B. International Residue Limits
In making its tolerance decisions, EPA seeks to harmonize U.S.
tolerances with international standards whenever possible, consistent
with U.S. food safety standards and agricultural practices. EPA
considers the international maximum residue limits (MRLs) established
by the Codex Alimentarius Commission (Codex), as required by FFDCA
section 408(b)(4). The Codex Alimentarius is a joint United Nations
Food and Agriculture Organization/World Health Organization food
standards program, and it is recognized as an international food safety
standards-setting organization in trade agreements to which the United
States is a party. EPA may establish a tolerance that is different from
a Codex MRL; however, FFDCA section 408(b)(4) requires that EPA explain
the reasons for departing from the Codex level. The Codex has not
established an MRL for alkyl amine polyalkoxylates.
VI. Conclusions
Therefore, the exemption from the requirement of a tolerance under
40 CFR 180.920 and 180.930 for alkyl amine polyalkoxylates is amended
to include CAS Reg. No. 1266162-49-5.
VII. Statutory and Executive Order Reviews
This final rule establishes a tolerance under FFDCA section 408(d)
in response to a petition submitted to the Agency. The Office of
Management and Budget (OMB) has exempted these types of actions from
review under Executive Order 12866, entitled ``Regulatory Planning and
Review'' (58 FR 51735, October 4, 1993). Because this final rule has
been exempted from review under Executive Order 12866, this final rule
is not subject to Executive Order 13211, entitled ``Actions Concerning
Regulations That Significantly Affect Energy Supply, Distribution, or
Use'' (66 FR 28355, May 22, 2001) or Executive Order 13045, entitled
``Protection of Children from Environmental Health Risks and Safety
Risks'' (62 FR 19885, April 23, 1997). This final rule does not contain
any information collections subject to OMB approval under the Paperwork
Reduction Act (PRA) (44 U.S.C. 3501 et seq.), nor does it require any
special considerations under Executive Order 12898, entitled ``Federal
Actions to Address Environmental Justice in Minority Populations and
Low-Income Populations'' (59 FR 7629, February 16, 1994).
Since tolerances and exemptions that are established on the basis
of a petition under FFDCA section 408(d), such as the tolerance in this
final rule, do not require the issuance of a proposed rule, the
requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et
seq.), do not apply.
This final rule directly regulates growers, food processors, food
handlers, and food retailers, not States or tribes, nor does this
action alter the relationships or distribution of power and
responsibilities established by Congress in the preemption provisions
of FFDCA section 408(n)(4). As such, the Agency has determined that
this action will not have a substantial direct effect on States or
tribal governments, on the relationship between the national government
and the States or tribal governments, or on the distribution of power
and responsibilities among the various levels of government or between
the Federal Government and Indian tribes. Thus, the Agency has
determined that Executive Order 13132, entitled ``Federalism'' (64 FR
43255, August 10, 1999) and Executive Order 13175, entitled
``Consultation and Coordination with Indian Tribal Governments'' (65 FR
67249, November 9, 2000) do not apply to this final rule. In addition,
this final rule does not impose any enforceable duty or contain any
unfunded mandate as described under Title II of the Unfunded Mandates
Reform Act of 1995 (UMRA) (2 U.S.C. 1501 et seq.).
This action does not involve any technical standards that would
require Agency consideration of voluntary consensus standards pursuant
to section 12(d) of the National Technology Transfer and Advancement
Act of 1995 (NTTAA) (15 U.S.C. 272 note).
VIII. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
EPA will submit a report containing this rule and other required
information to the U.S. Senate, the U.S. House of Representatives, and
the Comptroller General of the United States prior to publication of
the rule in the Federal Register. This action is not a ``major rule''
as defined by 5 U.S.C. 804(2).
List of Subjects in 40 CFR Part 180
Environmental protection, Administrative practice and procedure,
Agricultural commodities, Pesticides and pests, Reporting and
recordkeeping requirements.
Dated: September 28, 2012.
Lois Rossi,
Director, Registration Division, Office of Pesticide Programs.
Therefore, 40 CFR chapter I is amended as follows:
PART 180--[AMENDED]
0
1. The authority citation for part 180 continues to read as follows:
Authority: 21 U.S.C. 321(q), 346a and 371.
0
2. In Sec. 180.920, the table is amended by revising the following
inert ingredient to read as follows:
Sec. 180.920 Inert ingredients use pre-harvest; exemptions from the
requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% in Surfactants, related adjuvants of surfactants.
hydroxypoly(oxy-1,2-ethanediyl) C8- herbicide formulations
C18 saturated and unsaturated and 10% in insecticide
alkylamines; the poly(oxy-1,2- and fungicide
ethanediyl) content is 2-60 moles formulations.
(CAS Reg. Nos. 10213-78-2, 25307-17-
9, 26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7, 61791-
14-8, 61791-24-0, 61791-26-2, 61791-
31-9, 61791-44-4, 68155-33-9, 68155-
39-5, 68155-40-8,70955-14-5, 73246-
96-5, 1266162-49-5).
[[Page 61518]]
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0
3. In Sec. 180.930, the table is amended by revising the following
inert ingredient to read as follows:
Sec. 180.930 Inert ingredients applied to animals; exemptions from
the requirement of a tolerance.
* * * * *
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Inert ingredients Limits Uses
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* * * * * * *
N,N-Bis-[alpha]-ethyl-[omega]- Not to exceed 25% in Surfactants, related adjuvants of surfactants
hydroxypoly(oxy-1,2-ethanediyl) C8- herbicide formulations
C18 saturated and unsaturated and 10% in insecticide
alkylamines; the poly(oxy-1,2- and fungicide
ethanediyl) content is 2-60 moles formulations.
(CAS Reg. Nos. 10213-78-2, 25307-17-
9, 26635-92-7, 26635-93-8, 288259-
52-9, 58253-49-9, 61790-82-7, 61791-
14-8, 61791-24-0, 61791-26-2, 61791-
31-9, 61791-44-4, 68155-33-9, 68155-
39-5, 68155-40-8,70955-14-5, 73246-
96-5, 1266162-49-5).
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[FR Doc. 2012-24776 Filed 10-9-12; 8:45 am]
BILLING CODE 6560-50-P